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NCT02431247 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects
A Phase 3 study, sponsored by Janssen Sciences Ireland UC.
- Completed
- Registry status
- Phase 3
- Development phase
- 725
- Enrollment target
NCT02431247: Completed Phase 3 study, sponsored by Janssen Sciences Ireland UC.
NCT02431247 is a Phase 3 study that has completed, run by Janssen Sciences Ireland UC. The registered enrollment target is 725 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02431247, a Phase 3 study, has completed, sponsored by Janssen Sciences Ireland UC.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 725 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.
Primary Outcome
Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA \< 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to \[\>=
Interventions
- DRUG DRV/COBI FDC
- DRUG Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
- DRUG FTC/TDF FDC
- DRUG D/C/F/TAF FDC - Matching Placebo
- DRUG FTC/TDF FDC Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 725 participants |
| Start Date | 2015-07-06 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 3 |
What the finished NCT02431247 record still lists
NCT02431247 is an interventional study that assigns participants to a tested intervention. The registered 725 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which DRV/COBI FDC is the first listed.
NCT02431247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02431247 about?
NCT02431247 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects". The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) F...
What is the current status of trial NCT02431247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 725 participants. The study started on 2015-07-06. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT02431247?
The interventions under investigation include: DRV/COBI FDC (DRUG), Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC (DRUG), FTC/TDF FDC (DRUG), D/C/F/TAF FDC - Matching Placebo (DRUG), FTC/TDF FDC Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT02431247?
This trial is sponsored by Janssen Sciences Ireland UC, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02431247's enrollment target sits among peer trials
725 491st of 2000 higher than 1,510 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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